Evaluation of mHealth for Serious Mental Illness

August 10, 2021 updated by: Dror Ben-Zeev, University of Washington
This study is a waitlist control trial evaluating the acceptability and preliminary efficacy of a smartphone application with people with mental illness.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

315

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98195
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years or older
  • Owns an Android or iPhone smartphone with WiFi or 3G/4G capabilities (required for data transmission)
  • Has diagnosis of Schizophrenia, Schizoaffective Disorder, Bipolar Disorder or Major Depression
  • English speaker

Exclusion Criteria:

  • Does not live in the U.S.
  • Has already participated in the study
  • Unavailable for 60 days
  • Currently incarcerated or hospitalized

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Active
Instructed to download the app and use the app daily for 30 days.
Other: Smartphone App
The application consists of content areas focused on mental health.
ACTIVE_COMPARATOR: Waitlist Control
Waitlist control.
Other: Waitlist Control
Waitlist control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depressive Symptoms
Time Frame: Baseline, 30 days, 60 days
The Beck Depression Inventory is a self-reported 21-item inventory, scores range from 0-63 and items are summed to compute the total score. A higher score represents more depressive symptoms.
Baseline, 30 days, 60 days
Change in Paranoid Thinking
Time Frame: Baseline, 30 days, 60 days
The Green Paranoid Thoughts Scale Parts A & B is a 32-item scale, the total score is summed with a range of 16-80. A higher score represents more symptoms of paranoid thinking.
Baseline, 30 days, 60 days
Change in Anxiety Symptoms
Time Frame: Baseline, 30 days, 60 days
The Generalized Anxiety Disorder 7-item Scale is summed with a total score range of 0-21. Higher scores represent more symptoms of anxiety.
Baseline, 30 days, 60 days
Change in Psychotic Symptoms
Time Frame: Baseline, 30 days, 60 days
The Hamilton Program for Schizophrenia Voices Questionnaire is a 13-item questionnaire, 9 of the items are scored 0 (least severe or impairing) to 4 (most severe). The total score is intended to indicate the overall severity of psychotic symptoms. Total score range is 0-36. The remaining 4 items are intended to assess qualitative aspects.
Baseline, 30 days, 60 days
Participant Acceptability
Time Frame: 30 days
Participant Acceptability/Usability Ratings Scale is a 26-item scale measuring participant-rated acceptability of the intervention. Participants rate statements on a scale of Disagree (0), Neutral (1), or Agree (2). Items are summed to create a total score and a higher total score indicates greater acceptability.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 6, 2020

Primary Completion (ACTUAL)

May 1, 2021

Study Completion (ACTUAL)

May 1, 2021

Study Registration Dates

First Submitted

August 7, 2019

First Submitted That Met QC Criteria

August 22, 2019

First Posted (ACTUAL)

August 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2021

Last Update Submitted That Met QC Criteria

August 10, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00006898

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Schizophrenia

Clinical Trials on Smartphone App

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe